This invention relates to a sutureless closure for drawing together and retaining the edges of a wound or surgical incision.
Sutureless closures are well known in the art and have been used for some time to close wounds of various types. In most applications, the closure involves a pair of separate tapes, each having an adhesive backing so that the tapes can be attached to the skin on both sides of the wound. The tapes are cojoined by some type of connector to create a system for closing the wound and retaining it in this condition as it heals. Because the skin is not penetrated by the closure, no anesthesia is needed to install the system so long as the laceration is clean and does not require debridement. The system generally can be left in place longer than a suture system without having to compromise good cosmetic results and typically the sutureless system allows for easy access to the wound.
In one prevalent form of sutureless closure system, the adhesive tapes are joined by means of thread that is passed back and forth over the wound and which is somehow sewn into the tapes to close the system. Systems in which thread is used as the connecting element are shown in U.S. Pat. Nos. 345,541; 1,428,495; 1,969,188; 2,196,296 and 2,303,131. In all these systems, the thread lies very close to the skin in the wound area and can actually contact the wound particularly where swelling occurs. Consequently, the thread can pose a potential source of harm and/or infection at the laceration site. Sewing or tying the thread into the adhesive strips is also a relatively difficult task for the physician because of the lack of body provided by tape strips.
In a second type of sutureless closure system, elastic bands are utilized to cojoin adhesive backed strips and thus apply a constant closing force on the wound. In U.S. Pat. No. 2,018,517 a one piece elastic bandage is disclosed in which a gauze pad is placed under the center section thereof to cover and protect the wound area. This arrangement, of course, does not allow for ready access to the wound and also tends to apply pressure directly upon the wound rather than on the relatively undamaged edge regions. In U.S. Pat. Nos. 363,538 and 3,103,218, adhesive tapes positioned on both sides of the wound are provided with either vertically or horizontally disposed posts over which rubber bands are pasted. Here again the connecting elements lie close to, if not in actual contact with, the wound and require special attaching fixtures to hold the bands in place. The bands are not easily sterilized and are susceptible to breaking when exposed to water or the like.
Hasson in U.S. Pat. Nos. 3,698,395; 3,926,193 and 3,971,384 describes a number of different sutureless closure systems in which adhesive tapes are drawn together by means of a complex adjusting mechanism. For the most part, the Hasson mechanisms involve a ratchet-like device situated upon one tape that slidably engages a locking pawl seated upon an opposing tape. The pressure exerted by the system on the wound is adjusted by controlling the depth of penetration of the pawl into the ratchet. In a second embodiment, a bead chain is used to connect the tapes. One end of the chain is anchored on one tape and the chain adjustably received in a slotted passage carried on an opposing tape. In both cases, the adjusting mechanism is extremely complex and bulky. It is thus costly to manufacture and difficult to wear beneath clothing. Securing the adjustable components to the tapes poses special manufacturing problems and, in the case of the ratchet mechanism, alignment of the coacting parts present problems for the physician at the time of installation.
In U.S. Pat. No. 2,409,261 to Dow a series of wire connectors are placed under the tapes and are joined directly over the wound by twisting the wire ends together. By tightening the twists, the tapes can be drawn closer together. However, at the same time, the twisted wire is being shortened and thus driven down directly into the wound. Any amount of swelling in this area will cause the wire to become embedded in the wound where it can cause serious harm. The twisted wire ends also can easily catch or snap upon objects and the tapes are thus torn away from the skin causing the wound to reopen.
Kawehitch in U.S. Pat. No. 3,983,878 uses an elongated spring to draw a pair of specially prepared adhesive backed tapes together. The tapes, as well as the spring are complex and thus costly to manufacture. The spring, being a relatively rigid elongated member, presents alignment problems at the time of installation and because of the spring's special geometry is limited as to the areas in which it can be installed.
Many sutureless closures shown in the prior art do not evert the edges of the wound. Accordingly, good approximation of the skin layer alignment cannot be made which, quite often, produces infection or leads to eventual scarring.